Using nalbuphine for pain management in ARDS patients after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of nalbuphine, a semi-synthetic opioid, for managing pain and sedation in patients with Acute Respiratory Distress Syndrome (ARDS) following surgery. It is a single-center, randomized, single-blind, prospective trial comparing nalbuphine to sufentanil in critically ill patients. The study aims to assess how nalbuphine can improve patient comfort while minimizing adverse effects commonly associated with other opioids. The research focuses on patients who have undergone surgery within the last week and are experiencing moderate pain and anxiety in the ICU setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Had undergone surgical treatment within 7 days before enrollment;
* Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition Conference;
* Age ≥18 years old, gender unlimited;
* Patients admitted to ICU with CPOT score ≥3;
* Stay in ICU ≥48h;
* Sign the informed consent form.

Exclusion Criteria:

* APACHE II score ≥23 points;
* Patients with esophageal reflux disease and severe gastrointestinal injury have AGI score ≥3;
* Long-term use of narcotic analgesics, hypnotics and psychotropic drugs;
* Alcohol withdrawal symptoms;
* Severe liver dysfunction (Child-Pugh grade C);
* Patients with bronchial asthma and myasthenia gravis;
* Patients with severe craniocerebral injury, brain tumor, and increased intracranial pressure are prone to respiratory depression;
* Patients undergoing cardiac surgery under cardiopulmonary bypass;
* Patients who have been enrolled in other clinical trials;
* Study patients with drug allergy or other contraindications;
* Pregnant or lactating women;
* The patient himself or his legally authorized representative is unwilling to sign the informed consent;

Where it's running

• Department of Intensive Care Medicine
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Quanzhen Wang, doctor
• Email: wangquanzhen1986@163.com
• Phone: 15562570205

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Right‑heart function and heart–lung interaction during ARDS with mechanical ventilation

  This project will follow adults with ARDS on mechanical ventilation to see how positive‑pressure breathing affects the right heart over time and how that relates to circulation.

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• Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS

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  Recruiting Phase 1/2 PT. Prodia Stem Cell Indonesia · Jakarta Pusat, DKI Jakarta · NCT07439848

• Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

  This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.

  Recruiting Phase 1/2 Changchun Tuohua Pharmaceutical Co., Ltd. · Wuhan, Hubei · NCT07413978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.